FDA 483 - Creation Technologies Wisconsin Inc - July 20, 2023
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Creation Technologies Wisconsin Inc, a contract manufacturer in Oak Creek, WI, received a Form FDA 483 with three observations. The inspection revealed deficiencies in documenting equipment maintenance activities, including missing electronic signatures, and a failure to adequately update process control procedures following software revisions. Additionally, the firm was cited for inadequately establishing supplier requirements by miscategorizing a critical software supplier.
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